XKNIFE RADIOSURGERY SYSTEM— 510(k) K912630

Substantially Equivalent

Rsa, Inc.

FDA 510(k) clearance K912630 for XKNIFE RADIOSURGERY SYSTEM, Substantially Equivalent on 1991-11-04. Applicant: Rsa, Inc..

Clearance details

Applicant: Rsa, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1991-06-17
Decision date: 1991-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookline, MA, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.